Implantable articles for attaching tendons and/or ligaments to bone and/or cartilage, assemblies thereof, and methods of use thereof

ABSTRACT

An implantable article for attaching tendons and/or ligaments to bone and/or cartilage, assemblies thereof, and methods of use thereof are provided. The implantable article is configured for attaching at least one of a tendon and a ligament to at least one of bone and cartilage. The article comprises a membrane comprising a biological material that promotes cell growth. The membrane comprises an open end configured to receive a cell growth mixture, a closed end configured to be attached to the at least one of bone and cartilage, and a cavity extending from the open end to the closed end. The cavity is configured to receive the cell growth mixture from the open end.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation-in-part of U.S. patentapplication Ser. No. 15/482,711, which was filed on Apr. 7, 2017, andwhich claims priority to U.S. Provisional Patent Application No.62/319,783, which was filed on Apr. 7, 2016; and a continuation-in-partof U.S. patent application Ser. No. 15/482,696, which was filed on Apr.7, 2017, and which claims priority to U.S. Provisional PatentApplication No. 62/319,308, which was filed on Apr. 7, 2016. Thecontents of each are hereby incorporated by reference into thisspecification.

FIELD

The present application relates to implantable articles for attachingtendons and/or ligaments to bone, assemblies thereof, and methods of usethereof.

BACKGROUND

A tendon and/or a ligament can be degraded due to injury, infection,and/or disease. The degraded tendon and/or ligament may need to berepaired by a medical procedure to remedy the injury, infection, and/ordisease. There are challenges with current medical procedures to repairtendons and/or ligaments.

SUMMARY

The present disclosure provides an implantable article configured forattaching at least one of a tendon and a ligament to at least one ofbone and cartilage. The article comprises a membrane comprising abiological material that promotes cell growth. The membrane comprises anopen end configured to receive a cell growth mixture, a closed endconfigured to be attached to the at least one of bone and cartilage, anda cavity extending from the open end to the closed end. The cavity isconfigured to receive the cell growth mixture from the open end.

The present disclosure also provides a method for repairing at least oneof a tendon and a ligament. The method comprises contacting animplantable article configured to attach at least one of a tendon and aligament to at least one of bone and cartilage, with the at least one ofa tendon and a ligament. The article comprises a membrane comprising abiological material that promotes cell growth. The membrane comprises anopen end configured to receive a cell growth mixture, a closed endconfigured to be attached to the at least one of bone and cartilage, anda cavity extending from the open end to the closed end. The cavity isconfigured to receive the cell growth mixture from the open end. Themethod comprises introducing the cell growth mixture into the cavity ofthe implantable article and attaching the implantable article to atleast one of bone and cartilage with an anchor.

The present disclosure also provides an implantable article configuredfor attaching at least one of a tendon and a ligament to at least one ofbone and cartilage. The article comprises a first membrane, a secondmembrane, and a flange connecting the first membrane to the secondmembrane. The first membrane comprises a biological material thatpromotes cell growth. The first membrane comprises a first open endconfigured to receive a cell growth mixture, a first closed endconfigured to be attached to the at least one of bone and cartilage, anda first cavity extending from the first open end to the first closedend. The first cavity is configured to receive the cell growth mixturefrom the first open end. The second membrane comprises a first open endconfigured to receive the cell growth mixture, a second closed endconfigured to be attached to the at least one of bone and cartilage, anda second cavity extending from the second open end to the second closedend. The second cavity is configured to receive the cell growth mixturefrom the second open end.

The present disclosure also provides an implantable article configuredfor attaching at least one of a tendon and a ligament to at least one ofbone and cartilage. The article comprises an insertion tip, a reservoir,and a tube. The insertion tip comprises a biological material thatpromotes cell growth. The insertion tip comprises an open end configuredto receive a cell growth mixture, a closed end configured to be attachedto the at least one of muscle, a tendon, and a ligament, and a cavityextending from the open end to the closed end. The cavity is configuredto receive the cell growth mixture from the open end. The reservoircomprises the biological material. The reservoir is in fluidcommunication with the insertion tip and the reservoir is configured toreceive the cell growth mixture. The tube is in fluid communication withthe reservoir. The tube is configured to receive the cell growth mixtureand be attached to at least one of bone and cartilage.

It is understood that the inventions described in this specification arenot limited to the examples summarized in this Summary. Various otheraspects are described and exemplified herein.

BRIEF DESCRIPTION OF THE DRAWINGS

The features and advantages of the examples, and the manner of attainingthem, will become more apparent, and the examples will be betterunderstood by reference to the following description of examples takenin conjunction with the accompanying drawings, wherein:

FIG. 1 illustrates a schematic diagram of an implantable articleaccording to the present disclosure;

FIG. 2 illustrates a schematic diagram of an implantable articleattached to a base structure and an attachment structure according tothe present disclosure;

FIGS. 3A-G illustrate schematic diagrams of various steps in a methodfor repairing an attachment structure with the implantable article in afirst orientation according to the present disclosure;

FIGS. 4A-E illustrate schematic diagrams of various steps in a methodfor repairing an attachment structure with the implantable article in asecond orientation according to the present disclosure;

FIG. 5 illustrates an implantable article comprising a flange accordingto the present disclosure;

FIG. 6 illustrates an implantable article comprising a plurality ofmembrane projections according to the present disclosure;

FIG. 7 illustrates a schematic view of an implantable article comprisingan insertion tip, a reservoir, and a tube according to the presentdisclosure;

FIG. 8 illustrates a perspective view of a surgical kit according to thepresent disclosure;

FIG. 9 illustrates a flow chart for a method for repairing an attachmentstructure with an implantable device according to the presentdisclosure; and

FIG. 10 illustrates a cross-sectional side view of a tamping deviceaccording to the present disclosure.

Corresponding reference characters indicate corresponding partsthroughout the several views. The exemplifications set out hereinillustrate certain examples, in one form, and such exemplifications arenot to be construed as limiting the scope of the examples in any manner.

DETAILED DESCRIPTION

Various examples of the present disclosure will now be described toprovide an overall understanding of the principles of the composition,function, manufacture, and use of the compositions and methods disclosedherein. One or more examples are illustrated in the accompanyingdrawings. Those of ordinary skill in the art will understand that thecompositions, articles, and methods specifically described herein andillustrated in the accompanying drawings are non-limiting exemplaryexamples and that the scope of the various examples of the presentinvention is defined solely by the claims. The features illustrated ordescribed in connection with one exemplary example may be combined withthe features of other examples. Such modifications and variations areintended to be included within the scope of the present invention.

Reference throughout the specification to “various examples,” “someexamples,” “one example,” “an example,” or the like, means that aparticular feature, structure, or characteristic described in connectionwith the example is included in at least one example. Thus, appearancesof the phrases “in various examples,” “in some examples,” “in oneexample,” “in an example,” or the like, in places throughout thespecification are not necessarily all referring to the same example.Furthermore, the particular features, structures, or characteristics maybe combined in any suitable manner in one or more examples. Thus, theparticular features, structures, or characteristics illustrated ordescribed in connection with one example may be combined, in whole or inpart, with the features, structures, or characteristics of one or moreother examples without limitation. Such modifications and variations areintended to be included within the scope of the present examples.

Any numerical range recited in this specification describes allsub-ranges of the same numerical precision (i.e., having the same numberof specified digits) subsumed within the recited range. For example, arecited range of “1.0 to 10.0” describes all sub-ranges between (andincluding) the recited minimum value of 1.0 and the recited maximumvalue of 10.0, such as, for example, “2.4 to 7.6,” even if the range of“2.4 to 7.6” is not expressly recited in the text of the specification.Accordingly, the Applicant reserves the right to amend thisspecification, including the claims, to expressly recite any sub-rangeof the same numerical precision subsumed within the ranges expresslyrecited in this specification. All such ranges are inherently describedin this specification such that amending to expressly recite any suchsub-ranges will comply with the written description, sufficiency ofdescription, and added matter requirements.

Also, unless expressly specified or otherwise required by context, allnumerical parameters described in this specification (such as thoseexpressing values, ranges, amounts, percentages, and the like) may beread as if prefaced by the word “about,” even if the word “about” doesnot expressly appear before a number. Additionally, numerical parametersdescribed in this specification should be construed in light of thenumber of reported significant digits, numerical precision, and byapplying ordinary rounding techniques. It is also understood thatnumerical parameters described in this specification will necessarilypossess the inherent variability characteristic of the underlyingmeasurement techniques used to determine the numerical value of theparameters.

Notwithstanding that numerical ranges and parameters setting forth thebroad scope of the invention are approximations, numerical values areset forth in the specific examples are reported precisely as possible.Any numerical value, however, inherently contains certain errorsnecessarily resulting from the standard variation found in theirrespective testing measurements.

The grammatical articles “a,” “an,” and “the,” as used in thisspecification, including the claims, are intended to include “at leastone” or “one or more” unless otherwise indicated. Thus, the articles areused in this specification to refer to one or more than one (i.e., to“at least one”) of the grammatical objects of the article. By way ofexample, “a component” means one or more components, and thus, possiblymore than one component is contemplated and can be employed or used inan implementation of the described compositions, coatings, andprocesses. Nevertheless, it is understood that use of the terms “atleast one” or “one or more” in some instances, but not others, will notresult in any interpretation where failure to use the terms limitsobjects of the grammatical articles “a,” “an,” and “the” to just one.Further, the use of a singular noun includes the plural, and the use ofa plural noun includes the singular, unless the context of the usagerequires otherwise.

A tendon can be coupled directly to a muscle and attaches the muscle toanother structure such as, for example, a bone and/or cartilage. Aligament can attach non-muscle tissues, such as, for example, bonesand/or cartilage, to other non-muscle tissues. A tendon and a ligamentcan comprise flexible and non-stretchable bundles of collagen. As usedherein, the term “attachment structure” refers to a tendon, a ligament,or both a tendon and a ligament. As used herein, the term “basestructure” refers to bone, cartilage, or both bone and cartilage.

An attachment structure can become degraded, due to injury, infection,and/or disease as a result of, for example, a traumatic force and/or agradual deterioration. The degradation can be a partial or completerupture of the attachment structure. For example, a rupture of anattachment structure can be a partial or complete detachment of theattachment structure from a corresponding base structure or otherwiseweakening, loosening, or disrupting, of the attachment structure at alocation where the attachment structure was previously attached to thecorresponding base structure. Some ruptures may require a medicalprocedure in order to effectively and/or efficiently repair theattachment structure as the attachment structure may only have a limitedability to repair (e.g., regenerate, regrow, reattach) on its own. Forexample, an attachment structure may have a lower cell density and bloodsupply than muscles and/or internal organs which can make the repair ofthe attachment structure take longer than a muscle and/or internalorgan.

Thus, articles for attaching an attachment structure to a basestructure, assemblies thereof, and methods of use thereof are provided.The articles, assemblies, and methods as described in the disclosure canrepair various attachment structures. The articles, assemblies, andmethods can repair attachment structures in a joint, such as, forexample, a shoulder joint, a hip joint, an elbow joint, a knee joint, anankle joint, and/or a wrist joint. In various examples, the articles,assemblies, and methods of the present disclosure can repair theanterior cruciate ligament (ACL) in the knee joint and/or the tendonwhich attaches the supra-spinatus muscle to the humerus bone in theshoulder joint.

As illustrated in FIG. 1, an implantable article 100 comprising amembrane 102 is provided. The membrane 102 can comprise an open end 104,a closed end 106, and a cavity 108 extending from the open 104 to theclosed end 106. The membrane 102 can be configured to attach to a basestructure, an attachment structure, and/or a muscle. The membrane 102can be dissolved and/or reabsorbed by a base structure, attachmentstructure, and/or other surrounding elements. The membrane 102 cancomprise biological material that promotes cell growth (e.g., repair ofthe attachment structure), such as, for example, at least one of aplacental membrane, a collagen membrane, a carbohydrate matrix, abiocompatible polymer membrane, and a biologically derived membrane. Thebiological material can comprise the Atreon Bti scaffold-based productavailable from Atreon Orthopedics Columbus, Ohio. In various examples,the biological material can promote mammalian cell growth and softtissue repair. The membrane 102 can be a scaffold.

A placental membrane can comprise interface tissues obtained from aplacenta including the umbilical cord and amniotic sac. The biologicallyderived membrane can comprise synthetic collagenous meshes bonded tonatural membranes (e.g., skin, placental membranes) by usingbiocompatible adhesives. For example, the biologically derived membranecan comprise at least one of the crosslinked collagen mucopolysaccharidecomposite material as described in U.S. Pat. No. 4,060,081 to Yannas etal., the multilayer membrane as described in U.S. Pat. No. 4,060,081 toYannas et al., and a cell carrying collagenous membrane. In variousexamples, the membrane 102 can comprise a placental membrane attached toa collagen membrane with a soft and pliable interface of biocompatibleadhesive, such as, for example, polyacrylate, between them the placentalmembrane and the collagen membrane. The collagen membrane can comprisechemically crosslinked collagen fibers. The biocompatible polymer can bepolyvinyl alcohol, poly acrylamide, poly acrylate, and polyethyleneglycol.

The membrane 102 can be formed by various processes, such as, forexample, at least one of cutting, sewing, fusing, molding, pressing, andadditive manufacturing. For example, in order to form the membrane 102,a sheet of biological membrane can be formed in a desired shape.Thereafter, the sheet can be rolled into a substantially cylindricalshape and in various examples, an overlapping portion of the sheet inthe substantially cylindrical shape can be sealed. In various otherexamples, the overlapping portion is not sealed. An end of thesubstantially cylindrical shape can be sealed by, for example, foldingthe end over, fusing the end, and/or sewing the end in order to form themembrane 102. In yet another example, the membrane 102 can be additivelymanufactured into the desired configuration and shape. The membrane 102can be a single piece or multiple pieces.

The closed end 106 of the membrane 102 can comprise a bore suitable forreceiving a guide wire. The bore of the closed end 106 can be smallerthan a diameter of the open end 104 and the bore of the closed end 106can be occluded by a base structure and/or an attachment structure inorder to retain a cell growth mixture within the cavity 108.

The membrane 102 can comprise various levels of density, porosity,and/or permeability, which can affect the release of a cell growthmixture within the cavity 108 to the base structure, the attachmentstructure, and/or other surrounding elements. For example, the membrane102 can enable 75 percent of the cell count of the cell growth mixtureto diffuse through the membrane 102 from the cavity 108 after a day,such as, for example, after a week, after at least 2 weeks, after atleast 4 weeks, after at least 6 weeks, after at least 8 week, after atleast 10 weeks, after at least 12 weeks, or after at least 16 weeks. Themembrane 102 can enable 75 percent of the cell count of the cell growthmixture to diffuse through the membrane 102 from the cavity 108 after 16weeks or less, after 12 weeks or less, after 10 weeks or less, after 8weeks or less, after 6 weeks or less, after 4 weeks or less, after 2weeks or less, or after one week or less. The membrane 102 can enable 75percent of the cell count of the cell growth mixture to diffuse throughthe membrane 102 in a range of 1 day to 16 weeks, such as, for example,1 week to 10 weeks, or 2 weeks to 6 weeks.

The cell growth mixture can promote the repair of the attachmentstructure, such as, for example, growth of collagen fibers within theattachment structure. The cell growth mixture can comprise at least oneof stem cells, platelets, and spun fat. Stem cells can form into new andregenerated tissues and can be harvested from, for example, bone marrow.Thus, the cell growth mixture can comprise bone marrow. In variousexamples, the stem cells can comprise stromal precursor cells. Invarious examples, the cell growth mixture can comprise stromal precursorcells and spun fat as described in U.S. Patent Publication No.2012/0156177.

The platelets can release hormones, growth factors, and/or othermolecules that signal to other repair cells the location of thedegradation in the attachment structure and the need to repair thedegradation. The platelets can be obtained from platelet rich plasma.Thus, the cell growth mixture can comprise platelet rich plasma. Invarious examples, the cell growth mixture can also comprise additives,such as, for example, growth factors. In various examples, the cellgrowth mixture can facilitate the formation of collagen fibers and/orfacilitate deposition of collagen fibers onto the degraded attachmentstructure. The formation and/or deposition of the collagen fibers canfacilitate repair of the degraded attachment structure.

Bone marrow can be harvested from various bones in a human and/or ananimal. For example, a harvesting device, such as, for example, atrocar, can be penetrated into a bone. The trocar can penetrate throughthe cortex bone, the spongy bone, and into the bone marrow. A suctiondevice (e.g., an aspirator) can be used to remove (e.g., aspirate) adesired quantity of bone marrow out of the bone through the trocar. Theharvested bone marrow can be in a semi-liquefied form and can be used inthe cell growth mixture. The harvested bone marrow can be from a patientthat will receive the implantable device 100, a different patient, acadaver, and/or an animal.

Referring again to FIG. 1, the open end 102 of the membrane 102 can beconfigured to receive the cell growth mixture, and transport the cellgrowth mixture to the cavity 108 and, in various examples, the closedend 106. For example, the open end 102 can comprise a diameterconfigured to receive the cell growth mixture from an insertion guide,such as, for example, a cannula, a catheter (e.g., balloon catheter), asyringe, and/or a trocar.

The implantable article 100 and the closed end 106 can be configured tobe attached to a base structure and/or an attachment structure. Forexample, the closed end 106 can be attached to the base structure by astaple, a pin, a fastener (e.g., a screw), a suture, the dowel, and anadhesive.

In various examples, the open end 102 can be configured to receive adowel and transport the dowel to the cavity 108 and, in variousexamples, the closed end 106. The dowel can comprise, for example, atleast one of bone (e.g., cortex bone, spongy bone), a biocompatiblepolymer that can be dissolved and/or reabsorbed by a body of thesubject, and a biocompatible mineral. The biocompatible polymer cancomprise polyether ether ketone (e.g., PEEK). The biocompatible mineralcan comprise calcium phosphate containing mineral (e.g., apatite). Thebiocompatible mineral can be manufactured by facilitating crystal growthof the mineral to a desired shape, sintering a powder of the mineralinto a desired shape, and/or using a biocompatible glue to join a powderof the mineral together.

The dowel can be manufactured and/or harvested from various bones in ahuman and/or an animal, such as, for example a pelvic bone and/or afemur. The dowel can be harvested by using a harvesting device, such as,for example, a trocar in a procedure similar to how bone marrow washarvested as described above. The dowel can be harvested from a patientthat will receive the implantable device 100, a different patient, acadaver, and/or an animal. The dowel can be subjected to variousprocesses to minimize the risk of immune rejection, such as, forexample, removal of antigens that may provoke an immune response (e.g.,chemical treatments). In various other examples, the dowel can beadditively manufactured. In various examples, the dowel can comprisecortex bone from an outer portion of a pelvic bone at one end and spongybone that was disposed intermediate the cortex bone and bone marrow atanother end.

The dowel can comprise a generally cylindrical shape, a generallyelliptical shape, or a polygon shape. In various examples where thedowel comprises a generally cylindrical shape, the dowel can have adiameter of 0.5 inches or less, such as, for example, 0.25 inch or less,0.125 inch or less, 0.1 inch or less, 0.083 inch or less, 0.0625 inch orless, or 0.056 inch or less. The dowel can have a diameter of 0.01 inchor greater, such as, for example, 0.056 inch or greater, 0.0625 inch orgreater, 0.083 inch or greater, 0.1 inch or greater, 0.125 inch orgreater, or 0.25 inch or greater. The dowel can have a diameter in arange of 0.01 inch to 0.5 inch, such as, for example, 0.1 inch to 0.25inch or 0.0625 inch to 0.25 inch. A dowel harvested with a trocar canhave a diameter substantially similar to an internal diameter of thetrocar.

The dowel can have a length of 0.01 inch or greater, such as, forexample, 0.05 inch or greater, 0.1 inch or greater, 0.25 inch orgreater, 0.5 inch or greater, 0.75 inch or greater, or 1 inch orgreater. The dowel can have a length of 2 inch or less, such as, forexample, 1 inch or less, 0.75 inch or less, 0.5 inch or less, 0.25 inchor less, 0.1 inch or less, or 0.05 inch or less. The dowel can have alength in a range of 0.01 inch to 2 inch, such as, for example, 0.25inch to 1 inch or 0.25 to 0.75 inch. In various examples, the dowel canbe dynamically trimmed to accommodate a bore formed in the basestructure during a surgical procedure. The dowel can be pressed into abore formed in a base structure for a friction fit.

The membrane 102 can comprise a generally cylindrical shape, a generallyelliptical shape, and/or a polygon shape. The shape and/or permeabilityof the membrane 102 can enable cell growth mixture contained within thecavity to efficiently diffuse through the membrane 102 and into thesurrounding environment, such as, for example, a base structure, anattachment structure, and/or other surrounding elements. The shape ofthe membrane 102 can be configured to dispose a desired quantity of cellgrowth mixture proximal and/or adjacent to the attachment structurewhich can increase the rate at which collagen fiber can regrow in theattachment structure. For example, the membrane 102 can enable efficientdiffusion of the cell growth mixture in an interface area where theattachment structure may have ruptured. In various examples, themembrane 102 can comprise an expandable portion 110 a configured toincrease in size responsive to the cell growth mixture entering thecavity 108. The increase in size of the expandable portion 110 a canincrease the surface area of the membrane 102 which can increasediffusion of the cell growth mixture, a contact surface area between themembrane 102 and a base structure and/or attachment structure, and avolume of the cavity 108. In various examples, the membrane 102 cancomprise at least two expandable portions including expandable portion110 a.

The membrane 102 can be configured to be attached in an attachmentstructure and/or other resist removal. For example, the membrane 102 cancomprise retainers 180 on an outer surface 102 a. The retainers 180 canbe, for example, a protrusion, a barb, a spike, a hook, a bristle, aprong, and a spur. The retainers 180 can be oriented at an oblique anglerelative to the membrane 102 away from a direction of insertion of theimplantable article 100 to enable facile insertion of the membrane 102into a base structure, an attachment structure, and/or other surroundingelements. The oblique angle of the retainers 180 can inhibit or preventremoval of the membrane 102 from the base structure, the attachmentstructure, and/or other surrounding elements. In various examples, amembrane 102 comprising retainers 180 on the outer surface 102 a cancomprises a texture similar to shark skin. The retainers 180 cancomprise biological material. The retainers 180 can comprise the samematerial as the membrane 102 or a different material than the membrane102.

The retainers 180 can be formed integrally with the membrane 102 and/orin a secondary process. For example, the retainers 180 can be formed byat least one of molding, additively manufacturing, cutting, fusing, andmachining. The membrane 102 can be subjected to an accretion process,such as, for example, vapor deposition and/or crystal growth. Vapordeposition can comprise passing a fluid over a surface 102 a of themembrane 102 in a unidirectional manner so that the flow of the fluidwould control crystal growth in a desired direction. In various otherexamples, the retainers 180 can be cut into the membrane 102. In variousexamples, the retainers 180 can be molded integrally with the membrane102.

Referring to FIG. 2, the implantable article 100 can be inserted into anattachment structure 212 and attached to a base structure 214 by ananchor, such as, for example, a dowel 218. A bore 220 can be formed inthe base structure 214 by, for example, drilling prior to insertion ofthe implantable article 100. The closed end 106 of the implantablearticle can be placed in the bore 220 and the dowel 218 can be passedthrough the open end 204 of the membrane 102 and advanced through thecavity 108 until the dowel 218 forms a friction fit between an assemblyof the membrane 102 and dowel 218 and the bore 220. The friction fit canmaintain a position of the implantable article 100 relative to the basestructure 214. The dowel 218 can be substantially flush with a surfaceof the base structure 214, the dowel may protrude slightly from thesurface of the base structure 214, or the dowel can be slightly recessedwithin the base structure 214.

In various examples, the dowel 218 engages the closed end 106 of theimplantable article 100. In various examples where the dowel 218comprises cortex bone and spongy bone, the dowel 218 can be orientedsuch that a cortex bone portion of the dowel 218 is more proximal to theclosed end 106 than a spongy bone portion of the dowel 218. In variousexamples, a secondary anchor can be driven into the dowel 218 to expanda diameter of the dowel to increase a strength of the friction fit. Invarious other examples, implantable article 100 can be attached to thebase structure 214 by an anchor that may not comprise a dowel.

Cell growth mixture 216 can be introduced into the cavity 108 of theimplantable article 100 through the open end 104 of the membrane 102.The introduction of the cell growth mixture 216 to the cavity 108 can beperformed within minimal, if any, formation of air bubbles with the cellgrowth mixture 216 as the cavity 108 is filled. For example, a tip of ainsertion guide can be introduced into the cavity 108 until the tip ofthe insertion guide reaches the closed end 106 of the membrane 102 or inexamples comprising a dowel 218, the dowel 218. Then cell growth mixture216 can be introduced into the cavity 108 and, as the cavity 108 fills,the tip of the insertion device can be retracted from the cavity 108such that the tip may be proximal to the fill level of cell growthmixture 216 in the cavity 108.

The implantable device 100 can be configured to repair variousattachment structures. The repair of the attachment structure canposition the closed end 106 of the implantable device 100 proximal tothe base structure as shown in FIGS. 3A-G (e.g., a first orientation) orproximal to the attachment structure and/or muscle as shown in FIGS.4A-E (e.g., a second orientation).

Referring to FIGS. 3A-G, the implantable article 100 can be configuredto repair a tendon 322 connecting the corresponding supra-spinatusmuscle 324 to the humerus 326. The tendon 322 is shown as ruptured at alocation 328. As illustrated in FIG. 3A, the tendon 322 can be moved(e.g., pulled, pushed) until the tendon 322 is substantially alignedwith an attachment location 330 on a humeral head 326 a of the humerus326. Various types of devices, such as, for example, pliers, clamps,sutures, and guidewires, can be used for moving the tendon 322. Theattachment location 330 may vary depending on the extent and/or type ofrupture to the tendon 322.

A distance that the tendon 322 may have to be moved can be changed bymoving and/or orienting the humerus 326 such that the attachmentlocation 330 is closer to a socket 334 a of the scapula 334. Forexample, the humerus 326 can be rotated into an outward-extendingposition (not-shown) to reduce the distance that the tendon 322 may beneed to be moved to be substantially aligned with the attachmentlocation 330.

A guide wire 332 can be introduced into and through the tendon 322 andthen to the attachment location 330 on the humerus 326. Optionally, theguide wire 332 can pass through the supra-spinatus muscle 324 prior tothe tendon 322. The guide wire 332 can facilitate the insertion of theimplantable device 100 in a desired position and/or orientation relativeto the humerus 326 and the tendon 322.

As illustrated in FIG. 3B, a dilator 336 can be substantially alignedwith the guide wire 332 and advanced along the guide wire 332 in orderto deform tissue surrounding the guide wire 332 including the tendon 322in order to create a channel (not shown) configured to receive theimplantable article 100. The dilator 336 can be removed from the guidewire 332 and the channel in the tissue can remain. In various examples,a second dilator (not shown) different than the dilator 336 can besubstantially aligned with the guide wire 332 and advanced along theguide wire 332 in order to further deform the tissue surrounding theguide wire 332. For example, the second dilator can increase a diameterof the channel. In various examples, a balloon catheter can besubstantially aligned with the guide wire 332 and advanced along theguide wire 332 in order to deform tissue surrounding the guide wire 332.The quantity of and/or types of devices used to create the channel mayvary dependent on size of the tendon 322, size of the humerus 326,extent of the rupture, and/or a desired channel size or shape.

The dilator 336 can remain on the guide wire 332 and in the tissue whileanother device can be inserted within the dilator 336. As illustrated inFIG. 3C, an insertion guide 338 can be configured to introduce theimplantable article 100 to the attachment location 330. The implantablearticle 100 can be disposed on a tip of the insertion guide 338 and theinsertion guide 338 and implantable article 100 together can be advancedinto the tendon 322 and proximal to the attachment location 330utilizing the guide wire 332. The insertion guide 338 and implantablearticle 100 can be advanced through the dilator 336 and the dilator 336can be removed thereafter. The insertion guide 338 can comprise aninternal cavity configured to receive the guide wire 332 and theimplantable article 100 can comprise a bore on the closed end 106configured to receive the guide wire 332.

Upon inserting the implantable article 100 to a desired location, theguide wire 332 can be removed prior to an introduction of cell growthmixture into the cavity 108. Then, the cell growth mixture can beintroduced into the cavity 108 of the implantable article 100 by theinsertion guide 338. Upon introduction of the cell growth mixture to thecavity 108 of the membrane 102 of the implantable article 100, a size ofthe membrane 102 of the implantable article 100 can increase which canincrease a friction fit of the membrane 102 and surrounding tissue,increase diffusion of cell growth mixture through the membrane 102,and/or increase a volume of the cavity 108. As shown in FIG. 3D, theexpandable portion 110 a can increase in size responsive to the cellgrowth mixture being introduced to the cavity 108 of the implantablearticle 100. In various examples, the expandable portion 110 a can becomprise a diameter greater than a diameter of the membrane 102 prior tointroduction of the cell growth mixture to the cavity 108. For example,the expandable portion 110 a can be an enlarged portion of the membrane102. In various examples, a dowel can be inserted into the implantablearticle 100 utilizing the insertion guide 338 prior to introducing thecell growth mixture into the cavity 108 of the implantable article 100.The dowel can attach the closed end 106 of the membrane 102 of theimplantable article 100 to the humerus 326.

The membrane 102 of the implantable article 100 can be cut to a desiredlength. In various examples, the open end 104 of the implantable article100 can be pressed up against the tendon 322 and/or the supra-spinatusmuscle 324. As illustrated in FIG. 3E, the implantable article 100 canbe attached to the humerus 326 by an anchor 340. The anchor 340 can beattached prior to, during, and/or after filling the implantable articlewith cell growth mixture. The anchor 340 can attach the closed end 106of the implantable article to the humerus 346. Additional anchors can beinstalled as needed to attach the implantable article to the tendon 322and/or the humerus 346; or attach the tendon 322 to the humerus 346.

In various examples, the open end 104 of the implantable article 100 canbe sealed. For example, as shown in FIG. 3G, the open end 104 can besealed with a ring 382 (e.g., a PEEK ring), sutured, and/or otherwisesecured such that cell growth mixture can be retained within the cavity108 of the implantable article 100.

In various examples, additional cell growth mixture can be introducedinto the cavity 108 of the implantable article 102. The additional cellgrowth mixture can be added prior to cutting the implantable article toa desired length and/or sealing the open end 104. Upon introduction ofthe cell growth mixture to the cavity 108 of the membrane 102 of theimplantable article 100, a size of the membrane 102 of the implantablearticle 100 can further increase which can increase a friction fit ofthe membrane 102 and surrounding tissue, increase diffusion of cellgrowth mixture through the membrane 102, and/or increase a volume of thecavity 108. As shown in FIG. 3F, a second expandable portion 310 b ofthe membrane 102 can increase in size responsive to the additional cellgrowth mixture being introduced to the cavity 108 of the implantablearticle 100. The second expandable portion 310 b can be positionedwithin the tendon 322 or on an oppositely disposed surface of the tendon322 than the expandable portion 110 a is positioned. The multipleexpandable portions 110 a, 310 b can increase the contact surface areabetween the membrane 102 and the tendon 322 which can promote repair ofthe tendon 322 and/or increase a strength of the friction fit of theimplantable membrane 100 and the surrounding tissue.

Following the procedure to repair tendon 322, the insertion guide 338can be removed and incisions caused by the procedure can be closed. Theimplantable device 100 can remain in communication with the basestructure and/or attachment structure after the procedure to repairtendon 322 and can diffuse cell growth mixture into the surroundingtissue for a period of time. The implantable device 100, over time, canbe dissolved and/or reabsorbed by the humerus 326, the tendon 322,and/or other surrounding elements.

Referring to FIGS. 4A-E, the implantable article 100 can be configuredto repair a tendon 422 connecting the corresponding supra-spinatusmuscle 424 to the humerus 426. The tendon 422 is shown as ruptured at alocation 428. As illustrated in FIG. 4A, the tendon 422 can be moved(e.g., pulled, pushed) until the tendon 422 is substantially alignedwith an attachment location 430 on a humeral head 426 a of the humerus426.

A guide wire 432 can be introduced into and through the tendon 422 andthen to the supra-spinatus muscle 424. The guide wire 432 can facilitatethe insertion of the implantable device 100 in a desired position and/ororientation relative to the tendon 422.

As illustrated in FIG. 4B, a dilator 436 can be substantially alignedwith the guide wire 432 and advanced along the guide wire 432 in orderto deform tissue surrounding the guide wire 432 including the tendon 422and/or supra-spinatus muscle 424 in order to create a channel (notshown) configured to receive the implantable article 100.

The dilator 436 can remain on the guide wire 432 and in the tissue whileanother device can be inserted within the dilator 436. As illustrated inFIG. 4C, an insertion guide 438 can be configured to introduce theimplantable article 100 to the supra-spinatus muscle 424. Theimplantable article 100 can be disposed on a tip of the insertion guide438 and the insertion guide 438 and implantable article 100 together canbe advanced into the tendon 422 and supra-spinatus muscle 424 utilizingthe guide wire 432. The insertion guide 438 and implantable article 100can be advanced through the dilator 436 and the dilator 436 can beremoved thereafter. The insertion guide 438 can comprise an internalcavity configured to receive the guide wire 432 and the implantablearticle 100 can comprise a bore on the closed end 106 configured toreceive the guide wire 432. The implantable article 100 can compriseretainers 160 (not shown in FIGS. 4C-E) configured to inhibit or preventremoval of the implantable device 100 from the tendon 422 and/orsupra-spinatus muscle 424.

Upon inserting the implantable article 100 to a desired location, theguide wire 432 can be removed prior to an introduction of cell growthmixture into the cavity 108. Then, the cell growth mixture can beintroduced into the cavity 108 of the implantable article 100 by theinsertion guide 438. Upon introduction of the cell growth mixture to thecavity 108 of the membrane 102 of the implantable article 100, a size ofthe membrane 102 of the implantable article 100 can increase which canincrease a friction fit of the membrane 102 and surrounding tissue,increase diffusion of cell growth mixture through the membrane 102,and/or increase a volume of the cavity 108. As shown in FIG. 4D, theexpandable portion 110 a can increase in size responsive to the cellgrowth mixture being introduced to the cavity 108 of the implantablearticle 100.

The membrane 102 of the implantable article 100 can be cut to a desiredlength. As illustrated in FIG. 4E, the implantable article 100 can beattached to the humerus 426 by an anchor 440. The anchor 440 can beattached prior to, during, and/or after filling the implantable articlewith cell growth mixture. The anchor 440 can attach the open end 104 ofthe implantable article to the humerus 446. Additional anchors can beinstalled as needed to attach the implantable article to the tendon 422and/or the humerus 446; or attach the tendon 422 to the humerus 446.

Following the procedure to repair tendon 422, the insertion guide 438can be removed and incisions caused by the procedure can be closed. Theimplantable device 100 can remain in communication with the basestructure and/or attachment structure after the procedure to repairtendon 422 and can diffuse cell growth mixture into the surroundingtissue for a period of time. The implantable device 100, over time, canbe dissolved and/or reabsorbed by the humerus 426, the tendon 422,and/or other surrounding elements.

In various examples, a quantity of implantable devices used to repair adegraded attachment structure can be 2 or greater implantable devices,such as, for example, 3 or greater, 4 or greater, 5 or greater, 6 orgreater, 10 or greater, or 15 or greater implantable devices. A quantityof implantable devices used to repair a degraded attachment structurecan be 20 or less implantable devices, such as, for example, 15 or less,10 or less, 6 or less, 5 or less, 4 or less, or 3 or less implantabledevices. A quantity of implantable devices used to repair a degradedattachment structure can be in a range of 1 to 20 implantable devices,such as, for example, 1 to 3 implantable devices. In various examplescomprising a plurality of implantable devices, the implantable devicescan be positioned in attachment locations in a base structure which arearranged in two or more rows and each row can be positioned offset froman adjacent row (e.g., staggered). The offset positioning can limitundesired fractures in the base structure.

In various examples comprising at least two implantable devices, asingle staple can be driven into in two proximally positioned anchors(e.g., one leg in each implantable device). In various examplescomprising two or greater implantable devices, a connecting member(e.g., tape) can be attached to each anchor of each implantable deviceutilizing, for example, a biocompatible adhesive between the connectingmember and each anchor. The connecting member can provide a largecontact surface which can contact the attachment structure and maintaina position and/or orientation of the attachment structure.

As illustrated in FIG. 5, an implantable article 500 can be configuredwith a flange 542. For example, the implantable article 500 can besubstantially button shaped. The flange 542 can comprise biologicalmaterial. The flange 542 can comprise a generally round shape, agenerally elliptical shape, or a polygon shape (e.g., a tape-likeshape). For example, the flange 542 can be formed by attaching twolayers of a biological material to each other to form an annular cavity544 configured to receive cell growth mixture. The flange 542 cancomprise various geometric shapes configured to avoid any edges that mayirritate surrounding tissues. For example, the flange 542 may not haveany corners and the flange 542 may comprise a generally torus shape. Invarious other examples, the flange 542 may have a corner.

The flange 542 can increase the surface area of the implantable article500 which can promote the repair of the attachment structure. Theimplantable article 500 can be installed in a variety of positionsand/or orientations. For example, the implantable article 500 can beinserted into a base structure and the flange 542 can be positionedbetween the base structure and the attachment structure. The flange 522can be positioned flush against a base structure. In various otherexamples, the implantable article 500 can be inserted into an attachmentstructure and the flange 542 can be positioned between the basestructure and the attachment structure. The membrane 102 and/or flange544 of implantable article 500 can be secured to an attachment structureand/or base structure with an anchor.

As illustrated in FIG. 6, an implantable article 600 comprising aconnector 676 and a plurality of membrane projections 602 a-e. Eachmembrane projection 602 a-e can be configured as membrane 102 of FIG. 1.For example, each membrane projection 602 a-e can be attached to a basestructure and/or attachment structure. The connector 676 can join theplurality of membrane projections 602 a-e to one another and increasethe contact surface area between the implantable article 600 and theattachment structure. The increased contact surface area can distributeattachment forces across the attachment structure and can limit, if notprevent, additional degradation to the attachment structure. Themembrane projections 602 a-e can be positioned in offset rows along theconnector 676. The offset rows can minimize undesired fractures in abase structure in which they are installed. Additionally, the offsetrows can increase a spacing distance between adjacent membraneprojections 602 a-e while maintaining a compact overall implantablearticle 600 and a desired quantity of membrane projections 602 a-e. Forexample, the membrane projections 602 a-e can be spaced a distance in arange of 0.1 inches to 1 inch.

The implantable article 600 can be integrally formed with the connector676 or the membrane projections 602 a-e can be attached to the connector676 via a biocompatible adhesive. In various examples, the implantablearticle 600 can be integrally formed from a frozen mixture of crosslinked collagen fibers in water and lyophilizing the frozen mixture toremove the water molecules. The connector 676 can be a tape.

As illustrated in FIG. 7, an implantable article 700 comprising areservoir 746, a an insertion tip 748 a, and a tube 752 a is provided.The insertion tip 748 a can be configured to be attached to a muscleand/or an attachment structure. For example, the insertion tip 748 a canbe inserted into and retained by a muscle and/or an attachmentstructure. The insertion tip 748 a can comprise biological material andcan comprise retainers 780 disposed on an outer surface. The retainers780 can enable facile insertions of the insertion tips 748 a into amuscle and/or an attachment structure. The retainers 780 can inhibit orprevent removal of the insertion tip 748 a from the muscle and/or theattachment structure. The insertion tip 748 a can be attached to themuscle and/or attachment structure to maintain a position and/ororientation of the reservoir 746 relative to the muscle and/orattachment structure.

The insertion tip 748 a can comprise a cavity configured to receive thecell growth mixture and the insertion tip 748 a can increase in sizeresponsive to the receipt of the cell growth mixture. The increase insize of the insertion tip 748 a can increase the strength of attachmentbetween the insertion tip 748 a and the muscle, the base structure,and/or the attachment structure. In various examples, the implantablearticle 700 can comprise at least two insertion tips, such as, forexample, insertion tip 748 a and insertion tip 748 b, or the implantablearticle can comprise at least three insertion tips, such as, forexample, insertion tip 748 a, insertion tip 748 b, and insertion tip 748c.

A muscle can repair deformations caused by the insertion tips 748 a-cfaster than an attachment structure could repair deformations caused bythe insertion tips 748 a-c. Thus, in various examples, the insertiontips 748 a-c can be inserted into a muscle which can limit, if notprevent, undesired additional degradation to the attachment structure.For example, the insertion tips 748 a-c can be inserted into the musclecorresponding to a tendon. The implantable member 700 can be installedinto a side of the corresponding muscle proximal to the bone which canminimize, if not eliminate, additional degradation of the tendon whileenabling the reservoir 746 to be position proximal to a degradationpresent in the tendon.

The reservoir 746 can be in fluid communication with each insertion tip748 a-c and can receive cell growth mixture. For example, each insertiontip 748 a-c can comprise an open end adjacent to the reservoir 746 andan oppositely disposed closed end configured to attach to a muscleand/or the attachment structure. The open end of each insertion tip 748a-c can receive the cell growth mixture from the reservoir 746. Eachinsertion tip 748 a-c can comprise a cavity extending from theirrespective open end to their respective closed end.

The reservoir 746 can comprise biological material and can comprise adimension, d, which corresponds to a dimension of an attachmentstructure. For example, a tendon connecting the supraspinatus muscle tothe humerus can comprise a width of 1.5 cm to 2.5 cm, when pressedagainst a base structure and thus, the dimension, d, may be 1.5 cm to2.5 cm. In various examples, dimension, d, may be in a range of 1 cm to4 cm.

The tube 752 a can be in fluid communication with the reservoir 746 andcan receive a cell growth mixture. The tube 752 a can transport the cellgrowth mixture into the reservoir 746 and, in various examples, theinsertion tips 748 a-c. A length of the tube 752 a can be trimmed to adesired length which can be after the cell growth mixture has beentransported to the reservoir 746 and/or the insertion tips 748 a-c. Thetube 752 a can be attached to the base structure to maintain a positionand/or orientation of the reservoir 746 relative to the base structure.In various examples comprising trimming the length of tube 752 a, thetube 752 a can be attached to the base structure after trimming or thetube 752 a can be attached to the base structure before trimming. Invarious examples, the tube 752 a can be attached to a thread and/or atape and the thread and/or tape can be attached to the base structure tosecure the implantable article 700. In various examples, the implantablearticle 700 can comprise at least two tubes, such as, for example, tube752 a and tube 752 b, or the implantable article can comprise at leastthree tubes, such as, for example, tube 752 a, tube 752 b, and tube 752c.

The position of the reservoir 746 can change depending on the attachmentlocations of the insertion tips 748 a-c and the tubes 752 a-c. Invarious examples, the reservoir 746 is not directly attached to themuscle, base structure, and/or attachment structure by an anchor. Invarious other examples, the reservoir 746 is directly attached to atleast one of the muscle, the base structure, and attachment structure byan anchor.

The implantable article 700 can comprise various other elements, suchas, for example, a check valve positioned within the insertion tips 748a-c and/or tubes 752 a-c. The check valve can maintain a quantity ofcell growth mixture in the insertion tips 748 a-c and an increased sizeof the insertion tips 748 a-c which inhibit de-attachment of theimplantable article 700 while attaching the implantable article 700 to abase structure or during contraction of a corresponding muscle attachedto the tendon. For example, maintaining the increased size of theinsertion tips 748 a-c can maintain a friction fit between the insertiontips 748 a-c and a base structure and/or attachment structure.

The articles and methods according to the present disclosure can be forminimally-invasive surgery. As used herein, the term “surgery” refers toany type of tissue manipulation which penetrates the skin, and whichinvolves anything more than a single type of medical device, such as,for example, a guide wire, an insertion guide, a dilator, a needle, atamping device, and/or a trocar.

As illustrated in FIG. 8, a surgical kit 800 is provided which can beused to repair an attachment structure. The surgical kit 800 comprisesvarious components, such as, for example, a dilator tube set 860, atamping device set 862, and a biological material set 864. The dilatortube set 860 can comprise a single dilator tube or two or more dilatortubes. In examples comprising two or more dilator tubes, each tube cancomprise a different diameter and/or taper to enable efficient creationof a tunnel in soft tissue.

The tamping device set 862 can comprise a single tamping device or twoor more tamping devices. The tamping device set 862 can be configured tomanipulate soft tissues, move and/or press a attachment structure, moveand/or press a implantable device 100, 400, 500, 600, and/or providecontrol over insertion of an anchor into the implantable device 100,400, 500, 600, a base structure, and/or an attachment structure. Thetamping device set 862 can comprise tamping devices with variouslyshaped heads, such as, for example, planar, concave, convex, or angled.In various examples, the tamping device set 862 can comprise a tampingdevice with a textured surface. In various examples, the tamping deviceset 862 can comprise tamping device 1000 as illustrated in FIG. 10.

For example, the tamping device set 862 can comprise, for example, asuction tool as described in U.S. patent application Ser. No.15/482,696. The plunger of the suction tool can comprise a springactivated plunger. The actuator end of the tamping device can comprise adiameter in a range of 0.1 centimeters to 2 centimeters, such as, forexample, 0.8 centimeter to 1 centimeter.

In various examples, the tamping device set 862 can comprise, forexample, a tibial tamping tool as described in U.S. patent applicationSer. No. 15/482,696. The tibial tamping tool can comprise a springactivated head component. The head component of the tibial tamping toolcan be attached to the head component at an angle in a range of 15degrees to 30 degrees, such as, for example, 15 degrees to 20 degrees or20 degrees to 30 degrees. The tibial tamping tool can be attached to thehead component in the center of the head component or an end of the headcomponent.

The biological material set 864 can comprise at least one of theimplantable devices 100, 500, 600, 700 and/or raw material (e.g.,biological material) for producing at least one of the implantabledevices 100, 500, 600, 700. In examples comprising two or moreimplantable devices, each implantable device can comprise a differentsize, shape, and/or configuration.

The dilator tube set 860 can be sealed within a sterile envelope 870,the tamping device set 862 can be sealed within a sterile envelope 872,and the biological material set 864 can be sealed within a sterileenvelope 874. Each sterile envelope 870, 872, 874 can be opened prior touse. In various examples, at least two of the dilator tube set 860,tamping device set 862, and biological material 864 are stored withinthe same sterile envelope.

Each envelope 870, 872 can be formed from a backing layer 870 a, 872 a,and a sealing layer 870 a, 870 b attached to the respective backinglayer 870 a, 872 a around the periphery to create a seal. Each backinglayer 870 b, 872 b can be opaque and each sealing layer 870 a, 870 b canbe transparent. The transparent sealing layer 870 a, 870 b can enablequick identification of contents within each envelope 870, 872. Invarious examples, each envelope 870, 872 can be vacuum packed. Thelayers 870 a, 870 b, 872 a, 872 b can comprise a polymer. The upturnedcorners of layers 870 b, 872 b shown in FIG. 8 are for illustrationpurposed only and should not be considered limiting.

The envelope 874 can comprise a polymer, a metal, and/or a metal alloy.The envelope 874 can provide a sterile environment for the enclosedcontents. The biological material set 864 can be included as part of thesurgical kit 800 or separate from the surgical kit 800 as an independentcomponent which can be added at a later time to the container that holdsother components of the surgical kit 800.

Referring to FIG. 9, a method for repairing an attachment structure isprovided. As illustrated, an attachment structure that is degraded canbe prepared for surgery and optionally, the surrounding tissue can beprepared for surgery, 902. For example, at least one of the followingmay occur: the surrounding tissue may be manipulated (e.g., change theposition and/or orientation of the humerus relative to the scapula);movement of a base structure can be limited (e.g., a joint can besecured in a desired position); the surrounding tissue (e.g., skin) maybe disinfected and/or sterilized; anesthesia may be administered (localand/or general); an initial incision may be made in the surroundingtissue; a guide wire may be inserted into the attachment structureand/or surrounding tissue; a dilator may be inserted; a bore may beformed in the bone; a laser may be used to create nano-fractures on asurface of a bone which can enable diffusion of the cell growth mixtureinto the bone and/or enable diffusion of cells out of the bone; andvarious other procedures may occur.

An implantable article according to the present disclosure can becontacted with the attachment structure, 904. For example, theimplantable article according to the present disclosure can contact theattachment structure by inserting the implantable article according tothe present disclosure into the attachment structure and/or positioningthe implantable article according to the present disclosure adjacent tothe attachment structure. An insertion guide may be used to insertand/or position the implantable article according to the presentdisclosure. In various examples, an ultrasound or fluoroscope may beused to guide the insertion and/or positioning of the implantablearticle according to the present disclosure. In various examples, aguide wire may not be used if an ultrasound or fluoroscope device isused.

Cell growth mixture can be introduced into a cavity of the implantablearticle according to the present disclosure, 906. In examples where aninsertion guide comprising a catheter is used, the catheter can be usedto introduce the cell growth mixture into the cavity of the implantablearticle and fill the cavity with the cell growth mixture. Introductionof the cell growth mixture to the cavity can increase the size of anexpandable portion of a membrane of the implantable article according tothe present disclosure which can increase a surface area of theimplantable article according to the present disclosure. In variousexamples where the insertion guide is a balloon catheter, a balloon ofthe balloon catheter can increase the size of the expandable portion andback-fill the expandable portion with the cell growth mixture.

The implantable article according to the present disclosure can beattached to the base structure with an anchor, 908. The anchor can beinserted through various portions of the implantable article accordingto the present disclosure. For example, the anchor can be insertedthrough a closed end of the implantable article according to the presentdisclosure and then the base structure. The anchor can be installedbefore or after the introduction of the cell growth mixture to thecavity. The introduction of cell growth mixture to the cavity and theattachment of the implantable article to the base structure can berepeated as necessary, 912.

Thereafter, various other procedures may occur and the repair of theattachment structure method may be complete, 910. For example, any ofthe various medical devices (e.g., guide wires, dilators, catheters) maybe removed and any incisions may be closed.

Referring to FIG. 10, a tamping device 1000 is provided. The tampingdevice 1000 can comprise a shaft 1084, a head portion 1086, and a handleportion 1088. The head portion can comprise a diameter in a range of 0.1centimeters to 2 centimeters, such as, for example, 0.8 centimeter to 1centimeter. The shaft 1084 can operatively couple the head portion 1086to the handle portion 1088. The shaft 1084 can comprise a cavity 1084 aconfigured to receive a plunger 1090. The plunger 1090 can be undertension by a spring 1092. For example, the plunger 1090 is shown in afirst position. Upon activation of the plunger 1090 by pushing a firstend 1090 a of the plunger 1090, the plunger 1090 can move through thecavity 1084 a to a second position closer to the head portion 1086. Uponrelease of the plunger 1090 from the second position to the firstposition, a vacuum force can be created on a first side 1086 a of thehead portion 1086. Activating the plunger 1090 and moving the plunger1090 from the first position to the second position can release thevacuum force.

The tamping device 1000 can be used to apply a membrane 1094 to anattachment structure. For example, as illustrated, a membrane 1094comprising a biological material can be adhered to the first side 1086 aof the head portion 1086 by the vacuum force. The membrane 1094 cancomprise anchors 1040. A layer of cell growth mixture 1016 can beapplied to a side 1094 a of the membrane 1094. Thereafter, the membrane1094 and cell growth mixture 1016 can be applied to a partial orcomplete rupture of the attachment structure. The tamping device 1000can apply a force to the anchors 1040 in the membrane 1094 to secure theanchors 1040 to the attachment structure and/or a base structure therebysecuring the membrane 1094 and the layer of cell growth mixture 1016 tothe attachment structure and/or a base structure. Thereafter, theplunger 1090 can be activated from the first position to the secondposition to release the membrane 1094 and the layer of cell growthmixture 1016 from the tamping tool 1000 and the tamping tool 1000 can beseparated from the membrane 1094.

One skilled in the art will recognize that the herein describedcompositions, articles, methods, and the discussion accompanying themare used as examples for the sake of conceptual clarity and that variousconfiguration modifications are contemplated. Consequently, as usedherein, the specific exemplars set forth and the accompanying discussionare intended to be representative of their more general classes. Ingeneral, use of any specific exemplar is intended to be representativeof its class, and the non-inclusion of specific components (e.g.,operations), devices, and objects should not be taken as limiting.

Various aspects of the invention according to the present disclosureinclude, but are not limited to, the aspects listed in the followingnumbered clauses.

-   -   1. An implantable article configured for attaching at least one        of a tendon and a ligament to at least one of bone and        cartilage, the implantable article comprising:        -   a membrane comprising a biological material that promotes            cell growth, the membrane comprising:            -   an open end configured to receive a cell growth mixture;            -   a closed end configured to be attached to the at least                one of bone, cartilage, a tendon, and a ligament; and            -   a cavity extending from the open end to the closed end,                the cavity is configured to receive a cell growth                mixture from the open end.    -   2. The implantable article of clause 1, wherein the membrane        comprises a generally cylindrical shape or a generally        elliptical shape.    -   3. The implantable article of any one of clauses 1-2, wherein        the biological material comprises at least one of a placental        membrane, a collagen membrane, a carbohydrate matrix, a        biocompatible polymer membrane, and a biologically derived        membrane.    -   4. The implantable article of any one of clauses 1-3, wherein        the open end is configured to receive a dowel.    -   5. The implantable article of any one of clauses 1-4, further        comprising a flange attached to the membrane, the flange        comprising biological material and a flange cavity configured to        receive the cell growth mixture.    -   6. The implantable article of any one of clauses 1-5, further        comprising retainers on an outer surface of the membrane.    -   7. An assembly of the implantable article of claim 1 and an        anchor.    -   8. The assembly of clause 7, wherein the anchor comprises at        least one of a staple, a pin, a fastener, a suture, a dowel, and        an adhesive.    -   9. The assembly of clause 8, wherein the anchor comprises a        dowel.    -   10. The assembly of clause 9, wherein the dowel is formed from        additive manufacturing.    -   11. An assembly of the implantable article of claim 1 and a cell        growth mixture or the assembly of any one of clauses 7-10 and a        cell growth mixture.    -   12. The assembly of clause 11, wherein the cell growth mixture        comprises at least one of stem cells, platelets, and spun fat.    -   13. A surgical kit comprising the implantable article of any one        of clauses 1-6, a dilator tube set, and a tamping device set.    -   14. A method for repairing at least one of a tendon and a        ligament comprising:        -   contacting an implantable article with the at least one of            the tendon and the ligament, the implantable article            comprising:            -   a membrane comprising a biological material that                promotes cell growth, the membrane comprising:                -   an open end configured to receive a cell growth                    mixture;                -   a closed end configured to be attached to the at                    least one of bone, cartilage, a tendon, and a                    ligament; and                -   a cavity extending from the open end to the closed                    end, the cavity is configured to receive a cell                    growth mixture from the open end;        -   introducing a cell growth mixture into the cavity of the            implantable article; and        -   attaching the implantable article to at least one of bone            and cartilage with an anchor.    -   15. The method of clause 14, wherein attaching the implantable        article to the at least one of bone and the cartilage further        comprises:        -   forming a bore in the at least one of bone and cartilage;        -   inserting the closed end of the membrane into the bore; and        -   wherein the anchor comprises a dowel, inserting the dowel            through the cavity of the implantable article and creating a            friction fit between the membrane and the bore.    -   16. The method of clause 14,        -   wherein contacting an implantable article with the at least            one of the tendon and the ligament comprises inserting the            closed end of the membrane into at least one of the tendon            and the ligament; and        -   wherein attaching the implantable article to the at least            one of bone and the cartilage comprises attaching the open            end of the membrane to the at least one of the bone and the            cartilage with the anchor.    -   17. The method of any one of clauses 14-16, wherein introducing        the cell growth mixture into the cavity further comprises        increasing a size of the implantable article.    -   18. The method of any one of clauses 14-17, wherein the at least        one of the tendon and the ligament comprises at least one of an        anterior cruciate ligament and a tendon which attaches the        supra-spinatus muscle to a humerus.    -   19. An implantable article configured for attaching at least one        of a tendon and a ligament to at least one of bone and        cartilage, the article comprising:        -   a first membrane comprising a biological material that            promotes cell growth, the first membrane comprising:            -   a first open end configured to receive a cell growth                mixture;            -   a first closed end configured to be attached to the at                least one of the bone and the cartilage; and            -   a first cavity extending from the first open end to the                first closed end, the first cavity is configured to                receive the cell growth mixture from the first open end;        -   a second membrane comprising the biological material, the            second membrane comprising:            -   a second open end configured to receive the cell growth                mixture; and            -   a second closed end configured to be attached to the at                least one of the bone and the cartilage; and            -   a second cavity extending from the second open end to                the second closed end, the second cavity is configured                to receive the cell growth mixture from the second open                end; and        -   a flange connecting the first membrane to the second            membrane.    -   20. An implantable article configured for attaching at least one        of a tendon and a ligament to at least one of bone and        cartilage, the article comprising:        -   an insertion tip comprising a biological material that            promotes cell growth, the insertion tip comprising:            -   an open end configured to receive a cell growth mixture;            -   a closed end configured to be attached to at least one                of a muscle, a tendon, and a ligament; and            -   a cavity extending from the open end to the closed end,                the cavity is configured to receive a cell growth                mixture from the open end;        -   a reservoir comprising the biological material, the            reservoir is in fluid communication with the insertion tip            and the reservoir is configured to receive the cell growth            mixture; and

a tube in fluid communication with the reservoir, the tube is configuredto receive the cell growth mixture, transport the cell growth mixture tothe reservoir, and to be attached to the at least one of the bone andthe cartilage. With respect to the appended claims, those skilled in theart will appreciate that recited operations therein may generally beperformed in any order. Also, although various operational flows arepresented in a sequence(s), it should be understood that the variousoperations may be performed in other orders than those which areillustrated or may be performed concurrently. Examples of such alternateorderings may include overlapping, interleaved, interrupted, reordered,incremental, preparatory, supplemental, simultaneous, reverse, or othervariant orderings, unless context dictates otherwise. Furthermore, termslike “responsive to,” “related to,” or other past-tense adjectives aregenerally not intended to exclude such variants, unless context dictatesotherwise.

Various features and characteristics are described in this specificationto provide an understanding of the composition, structure, production,function, and/or operation of the invention, which includes thedisclosed compositions, coatings, and methods. It is understood that thevarious features and characteristics of the invention described in thisspecification can be combined in any suitable manner, regardless ofwhether such features and characteristics are expressly described incombination in this specification. The Inventors and the Applicantexpressly intend such combinations of features and characteristics to beincluded within the scope of the invention described in thisspecification. As such, the claims can be amended to recite, in anycombination, any features and characteristics expressly or inherentlydescribed in, or otherwise expressly or inherently supported by, thisspecification. Furthermore, the Applicant reserves the right to amendthe claims to affirmatively disclaim features and characteristics thatmay be present in the prior art, even if those features andcharacteristics are not expressly described in this specification.Therefore, any such amendments will not add new matter to thespecification or claims and will comply with the written description,sufficiency of description, and added matter requirements.

The invention(s) described in this specification can comprise, consistof, or consist essentially of the various features and characteristicsdescribed in this specification. The terms “comprise” (and any form ofcomprise, such as “comprises” and “comprising”), “have” (and any form ofhave, such as “has” and “having”), “include” (and any form of include,such as “includes” and “including”), and “contain” (and any form ofcontain, such as “contains” and “containing”) are open-ended linkingverbs. Thus, a composition, coating, or method that “comprises,” “has,”“includes,” or “contains” one or more features and/or characteristicspossesses those one or more features and/or characteristics but is notlimited to possessing only those one or more features and/orcharacteristics. Likewise, an element of a composition, coating, orprocess that “comprises,” “has,” “includes,” or “contains” one or morefeatures and/or characteristics possesses those one or more featuresand/or characteristics but is not limited to possessing only those oneor more features and/or characteristics and may possess additionalfeatures and/or characteristics.

Any patent, publication, or other document identified in thisspecification is incorporated by reference into this specification inits entirety unless otherwise indicated but only to the extent that theincorporated material does not conflict with existing descriptions,definitions, statements, illustrations, or other disclosure materialexpressly set forth in this specification. As such, and to the extentnecessary, the express disclosure as set forth in this specificationsupersedes any conflicting material incorporated by reference. Anymaterial, or portion thereof, that is incorporated by reference intothis specification, but which conflicts with existing definitions,statements, or other disclosure material set forth herein, is onlyincorporated to the extent that no conflict arises between thatincorporated material and the existing disclosure material. Applicantreserves the right to amend this specification to expressly recite anysubject matter, or portion thereof, incorporated by reference. Theamendment of this specification to add such incorporated subject matterwill comply with the written description, sufficiency of description,and added matter requirements.

While the present disclosure provides descriptions of various specificaspects for the purpose of illustrating various aspects of the presentdisclosure and/or its potential applications, it is understood thatvariations and modifications will occur to those skilled in the art.Accordingly, the invention or inventions described herein should beunderstood to be at least as broad as they are claimed and not as morenarrowly defined by particular illustrative aspects provided herein.

What is claimed is:
 1. An implantable article configured for attachingat least one of a tendon and a ligament to at least one of bone andcartilage, the implantable article comprising: a membrane comprising abiological material that promotes cell growth, the membrane comprising:an open end configured to receive a cell growth mixture; a closed endconfigured to be attached to at least one of the bone, the cartilage,the tendon, and the ligament; and a cavity extending from the open endto the closed end, the cavity is configured to receive a cell growthmixture from the open end; and a flange attached to the membrane, theflange comprising biological material and a flange cavity configured toreceive the cell growth mixture.
 2. The implantable article of claim 1,wherein the membrane comprises a generally cylindrical shape or agenerally elliptical shape.
 3. The implantable article of claim 1,wherein the biological material comprises at least one of a placentalmembrane, a collagen membrane, a carbohydrate matrix, a biocompatiblepolymer membrane, and a biologically derived membrane.
 4. Theimplantable article of claim 1, wherein the open end is configured toreceive a dowel.
 5. The implantable article of claim 1, furthercomprising retainers on an outer surface of the membrane.
 6. An assemblyof the implantable article of claim 1 and an anchor.
 7. The assembly ofclaim 6, wherein the anchor comprises at least one of a staple, a pin, afastener, a suture, a dowel, and an adhesive.
 8. The assembly of claim7, wherein the anchor comprises a dowel.
 9. The assembly of claim 8,wherein the dowel is formed from additive manufacturing.
 10. An assemblyof the implantable article of claim 1 and a cell growth mixture.
 11. Theassembly of claim 10, wherein the cell growth mixture comprises at leastone of stem cells, platelets, and spun fat.
 12. A surgical kitcomprising the implantable article of claim 1, a dilator tube set, and atamping device set.
 13. A method for repairing at least one of a tendonand a ligament comprising: contacting an implantable article with the atleast one of the tendon and the ligament, the implantable articlecomprising: a membrane comprising a biological material that promotescell growth, the membrane comprising: an open end configured to receivea cell growth mixture; a closed end configured to be attached to atleast one of bone, cartilage, the tendon, and the ligament; and a cavityextending from the open end to the closed end, the cavity is configuredto receive a cell growth mixture from the open end; introducing a cellgrowth mixture into the cavity of the implantable article; and attachingthe implantable article to at least one of the bone and the cartilagewith an anchor.
 14. The method of claim 13, wherein the at least one ofthe tendon and the ligament comprises at least one of an anteriorcruciate ligament and a tendon which attaches the supra-spinatus muscleto a humerus.
 15. The method of claim 13, wherein attaching theimplantable article to the at least one of the bone and the cartilagefurther comprises: forming a bore in the at least one of the bone andthe cartilage; inserting the closed end of the membrane into the bore;and wherein the anchor comprises a dowel, inserting the dowel throughthe cavity of the implantable article and creating a friction fitbetween the membrane and the bore.
 16. The method of claim 13, whereinintroducing the cell growth mixture into the cavity further comprisesincreasing a size of the implantable article.
 17. The method of claim13, wherein contacting an implantable article with the at least one ofthe tendon and the ligament comprises inserting the closed end of themembrane into the at least one of the tendon and the ligament; andwherein attaching the implantable article to the at least one of thebone and the cartilage comprises attaching the open end of the membraneto the at least one of the bone and the cartilage with the anchor. 18.An assembly configured for attaching at least one of a tendon and aligament to at least one of bone and cartilage, the assembly comprising:a dowel configured to be pressed into a bore formed in the at least oneof the bone and the cartilage for a friction fit; and an implantablearticle comprising: a membrane comprising a biological material thatpromotes cell growth, the membrane comprising: an open end configured toreceive a cell growth mixture and the dowel; a closed end configured tobe attached to the at least one of the bone and the cartilage; and acavity extending from the open end to the closed end, the cavity isconfigured to receive the cell growth mixture from the open end.
 19. Animplantable article configured for attaching at least one of a tendonand a ligament to at least one of bone and cartilage, the articlecomprising: an insertion tip comprising a biological material thatpromotes cell growth, the insertion tip comprising: an open endconfigured to receive a cell growth mixture; a closed end configured tobe attached to at least one of a muscle, a tendon, and a ligament; and acavity extending from the open end to the closed end, the cavity isconfigured to receive a cell growth mixture from the open end; areservoir comprising the biological material, the reservoir is in fluidcommunication with the insertion tip and the reservoir is configured toreceive the cell growth mixture; and a tube in fluid communication withthe reservoir, the tube is configured to receive the cell growthmixture, transport the cell growth mixture to the reservoir, and to beattached to the at least one of the bone and the cartilage.
 20. Theassembly of claim 19, wherein the dowel comprises at least one materialselected from the group consisting of bone, polyether ether ketone, andapatite.